(268 days)
No
The document describes a contrast media management system with hardware and software controls for safe operation, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
Explanation: The device is used for the administration of contrast media and saline in diagnostic CT examinations, which aids in imaging and diagnosis rather than directly treating a disease or condition.
No
The device is a contrast media management system used to administer contrast media and saline to patients undergoing diagnostic CT examinations. It does not perform the diagnosis itself.
No
The device description explicitly states that the system consists of hardware components (CT motion terminal, CT motion injector, CT motion tubing system, peristaltic pump) in addition to software controls. It is a physical device with software controlling its operation.
Based on the provided text, the ulrichINJECT CT motion is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "controlled, automatic administration, on the venous side, of contrast media and saline... to human subjects undergoing diagnostic examinations in computed tomography (CT) applications." This describes a device used in vivo (within a living organism) for administering substances during a medical procedure.
- Device Description: The description details a system that delivers fluids into the patient's bloodstream via tubing and a peristaltic pump. This is consistent with an in vivo administration device.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The ulrichINJECT CT motion does not perform any analysis or testing of biological specimens.
Therefore, the ulrichINJECT CT motion is an in vivo medical device used for administering contrast media and saline during CT scans.
N/A
Intended Use / Indications for Use
ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCI), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.
ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.
Pump tubing-flex is used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, Omnipaque™ single dose bottles, or Visipaque™ single dose bottles, a maximum of 19 bottles of contrast media can be used or maximum time of twenty four (24) hours of Pump tubing-flex, or whichever comes first. Time per contrast media or saline container depends on each contrast media’s or saline’s use time expiration with a maximum of eight (8) hours per contrast media or saline container.
Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulrichINJECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
Product codes (comma separated list FDA assigned to the subject device)
IZQ
Device Description
ulrichINJECT CT motion is a syringeless contrast media management system that is designed for the controlled, automatic administration, on the venous side, of contrast media and saline, to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.
The ulrichINJECT CT motion system consists of the CT motion terminal, CT motion injector and the CT motion tubing system. The CT motion tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The CT motion tubing system consists of three components:
- . Spike for CT
- . Pump tubing-flex
- . Patient Tubing
ulrichINJECT CT motion uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the CT motion tubing system (spikes for CT, CT motion pump tubing-flex, and patient tubing for pump tubing-flex).
The updated ulrichINJECT CT motion system is intended to be used with the following components that are not supplied with the system:
- Multiple patient use saline containers, .
- Omnipaque IBP contrast media containers, .
- . Omnipaque single-dose contrast media bottles,
- . Visipaque single-dose contrast media bottles, and
- . Cannula.
The updated ulrichINJECT CT motion system is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.
ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the device. Controls include air detectors, which are designed to detect air without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.
The ulrichINJECT CT motion is provided in three versions:
- . Mobile pedestal version
- Ceiling version ●
- Wall mounted version ●
The mobile pedestal version consists of the iniector head and the iniector base and has been updated to operate with a rechargeable Li-ion battery or lead gel battery in addition to the power supply. The ceiling version and the wall mounted version consist of the injector head, a fixed height arm, and a movable arm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ulrichINJECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ulrichINJECT CT motion system and software were validated in accordance with a Verification & Validation plan to ensure conformance with established performance criteria. Software verification and validation was performed as part of K171392 and has been repeated for the software updates made as part of this submission. FDA's guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA Staff" (2005) has been followed. Validation included an installation qualification and an operational / performance qualification. The ulrichINJECT CT motion software is unconditionally acceptance criteria for the Installation Qualification and Operational and Performance Qualification are satisfactorily met so that the Software is released for its intended use.
Electromagnetic Compatibility / Electrical Safety: Testing was performed in accordance with IEC 60601-1 and IEC 60601-2 as part of K171392. Additional EMC Testing has been performed to demonstrate conformance to IEC 60601-1-2 4th edition. Testing results indicate compliance with the standards.
Sterilization: The ulrichINJECT CT motion tubing system is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10-6 in accordance with ISO 11135-1:2007. Verification results indicate compliance with the standard.
Shelf-Life: Real-time aging and accelerating aging studies were performed as part of K171392, with additional real-time aging shelf-life data provided for this submission. Packaging was validated in accordance with ISO 11607-1:2006. Verification results indicate compliance with the standard.
Chemical Compatibility: Material compatibility of the ulrichINJECT CT motion tubing system was performed using Omnipaque™ and Visipaque™ as solvents. Results concluded no interaction with Omnipaque™ or Visipaque™ and no compromise to their chemical integrity, indicating the device is safe and effective for its intended uses.
Contamination Control: Studies included Process Simulation, Microbial Ingress, Cross Contamination, and Rinsing. Results concluded that ulrichINJECT CT motion can maintain sterility of injection media and resist microorganism ingress when used with Omnipaque™ IBP, Omnipaque single dose bottles, and Visipaque single dose bottles. Residuals between Iohexol and Iodixanol after rinsing were within defined limits.
Biocompatibility: Indirect patient contact materials were verified in accordance with ISO 10993-1:2009 as part of K171392. Tests performed included Cytotoxicity, Intracutaneous reactivity, Allergic sensitization, Systemic acute toxicity, Pyrogens, Hemocompatibility (Hemolysis), and LAL test (Bacterial endotoxins). Verification results indicated material compliance with the standard.
Extractables and Leachables: Testing for extractables and simulation testing for leachable compounds and particulates was performed as part of K171392 for OMNIPAQUE and repeated for VISIPAQUE for this submission. Testing and toxicological assessment demonstrated safety and effectiveness for intended uses, meeting pre-defined acceptance criteria.
Performance - Bench: The ulrichINJECT CT motion tubing system was tested for performance and verified in accordance with applicable requirements of ISO 8536-4:2010 as part of K171392. Transport validation and cleaning instructions validation were also performed as part of K171392. Additional verification testing was performed to confirm no mixing of contrast media occurs. Test and verification results indicate conformance to predetermined specifications and applicable standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 2, 2020
ulrich GmbH & Co. KG % Rita King CEO MethodSense, Inc. 1 Copley Parkway. Suite 410 Morrisville, North Carolina 27560
Re: K192872
Trade/Device Name: ulrichINJECT CT Motion Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: IZO Dated: May 29, 2020 Received: June 2, 2020
Dear Rita King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 1 of 1
3
Summary of 510(k)
Ulrich GmbH & Co. KG
K192872
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | ulrich GmbH & Co. KG
Buchbrunnenweg 12
89081 Ulm
Germany
Phone: +49 731 9654-1714
Fax: +49 731 9654-2807 |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Sven Erdmann
Director Development & Product Management Devices |
| Date Prepared: | May 29, 2020 |
Device Name and Classification
| Trade Name: | ulrichINJECT CT motion |
|---|---|
| Common Name: | Contrast Media Management System |
| Classification: | Class II |
| Regulation Number: | 21 CFR 870.1650, Angiographic Injector and Syringe |
| Classification Panel: | Cardiovascular Panel |
| Product Code: | IZQ |
Predicate Device:
| Predicate | |
|---|---|
| Trade Name | ulrichINJECT CT motion |
| Common Name | Contrast Media Management System |
| 510(k) Submitter / Holder | Class II |
| 510(k) Number | K171392 |
| Regulation Number | 21 CFR 870.1650, Angiographic Injector and Syringe |
| Classification Panel | Cardiovascular Panel |
| Product Code | IZQ |
4
Device Description
ulrichINJECT CT motion is a syringeless contrast media management system that is designed for the controlled, automatic administration, on the venous side, of contrast media and saline, to human subjects underqoing diagnostic examinations in computed tomography (CT) applications.
The ulrichINJECT CT motion system consists of the CT motion terminal, CT motion injector and the CT motion tubing system. The CT motion tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The CT motion tubing system consists of three components:
- . Spike for CT
- . Pump tubing-flex
- . Patient Tubing
ulrichINJECT CT motion uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the CT motion tubing system (spikes for CT, CT motion pump tubing-flex, and patient tubing for pump tubing-flex).
The updated ulrichINJECT CT motion system is intended to be used with the following components that are not supplied with the system:
- Multiple patient use saline containers, .
- Omnipaque IBP contrast media containers, .
- . Omnipaque single-dose contrast media bottles,
- . Visipaque single-dose contrast media bottles, and
- . Cannula.
The updated ulrichINJECT CT motion system is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.
ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the device. Controls include air detectors, which are designed to detect air without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.
The ulrichINJECT CT motion is provided in three versions:
- . Mobile pedestal version
- Ceiling version ●
- Wall mounted version ●
5
The mobile pedestal version consists of the iniector head and the iniector base and has been updated to operate with a rechargeable Li-ion battery or lead gel battery in addition to the power supply. The ceiling version and the wall mounted version consist of the injector head, a fixed height arm, and a movable arm.
Indications for Use
ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCI), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.
ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.
Pump tubing-flexis used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, Omnipaque™ single dose bottles, or Visipaque™ single dose bottles, a maximum of 19 bottles of contrast media can be used or maximum time of twenty four (24) hours of Pump tubing-flex, or whichever comes first. Time per contrast media or saline container depends on each contrast media's or saline's use time expiration with a maximum of eight (8) hours per contrast media or saline container.
Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulrichINJECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
Risk Analvsis Method
The updated ulrichINJECT CT motion system was assessed to determine the risks to health associated with the use of the device specifically as it relates to the use of OMNIPAQUE and VISIPAQUE single dose bottles and the new Li-ion battery. Risks related to safety. contamination and usability were considered. A risk analysis was conducted in accordance with ISO 14971:2007, Medical devices -- Application of risk management to medical devices. Several risks were assessed, including, but not limited to, device malfunction, mixing of contrast media, contamination and infection, and improper use.
Substantial Equivalence
ulrichINJECT CT motion is substantially equivalent to the ulrichINJECT CT motion system (K171392) currently on the market.
The table below provides a detailed comparison of ulrichINJECT CT motion to the predicate device.
6
Detailed Comparison of the Subject and Predicate Device
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | ulrichINJECT CT motion is a contrast
media management system that is
indicated for the controlled, automatic
administration, on the venous side, of
contrast media and saline (NaCl), to
human subjects undergoing diagnostic
examinations in computed tomography
(CT) applications.
ulrichINJECT CT motion is specifically
indicated for use in CT procedures for
the delivery of Omnipaque™ (lohexol)
Injection, solution - GE Healthcare Inc.
contrast media as supplied in Imaging
Bulk Packages (IBP), Omnipaque™
(lohexol) Injection, solution – GE
Healthcare Inc., and Visipaque™
(iodixanol) Injection - GE Healthcare
Inc. contrast media as supplied in
single dose bottles.
Pump tubing-flex is used for a
maximum time of twenty four (24)
hours. When used with Omnipaque™
IBP, Omnipaque™ single dose bottles,
or Visipaque™ single dose bottles, a
maximum of 19 bottles of contrast
media can be used or maximum time
of twenty four (24) hours of Pump
tubing-flex, or whichever comes first.
Time per contrast media or saline
container depends on each contrast | ulrichINJECT CT motion is a contrast
media management system that is
indicated for the controlled, automatic
administration, on the venous side, of
contrast media and saline, to human
subjects undergoing diagnostic
examinations in computed tomography
(CT) applications.
ulrichINJECT CT motion is specifically
indicated for use in CT procedures for
the delivery of Omnipaque™ (lohexol)
Injection, solution - GE Healthcare Inc.
contrast media as supplied in Imaging
Bulk Packages (IBP).
Pump tubing-flex is used for a
maximum time of twenty four (24)
hours. When used with Omnipaque™
IBP, a maximum of 19 bottles of
contrast media can be used or
maximum time of twenty four (24)
hours of pump tubing-flex, or
whichever comes first, with a maximum
of eight (8) hours per contrast media or
saline container.
Spike for CT disposable is for single-
bottle use only and must be discarded
with the media container. The patient
tubing must be discarded after each
patient procedure. | The intended use of the
ulrichINJECT CT motion is
identical to the intended use of
the previously cleared
ulrichINJECT CT motion
(K171392).
The indications for use of the
ulrichINJECT CT motion are
equivalent to the indications
for use of the previously
cleared ulrichINJECT CT
motion (K171392).
The only difference is that the
ulrichINJECT CT motion
supports two additional
contrast media, OMNIPAQUE
single dose and VISIPAQUE
single dose. This difference
does not affect the intended
use or safety and
effectiveness of the device. |
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
| | media's or saline's use time expiration,
with a maximum of eight (8) hours per
contrast media or saline container.
Spike for CT disposable is for single-
bottle use only and must be discarded
with the media container. The Patient
tubing must be discarded after each
patient procedure.
ulrichINJECT CT motion is to be used
only by and under quasi-continuous
supervision of trained healthcare
professionals in an appropriate
licensed healthcare facility, in a room
designated for radiological procedures
that involve intravascular
administration of contrast agent. | ulrichINJECT CT motion is to be used
only by and under quasi-continuous
supervision of trained healthcare
professionals in an appropriate
licensed healthcare facility, in a room
designated for radiological procedures
that involve intravascular
administration of contrast agent. | |
| System Components | | | |
| System | Injector Head
Touch Terminal | Injector Head
Touch Terminal | The system components of the
ulrichINJECT CT motion are
identical to the system
components of the previously
cleared ulrichINJECT CT
motion (K171392). |
| Accessories | Injector Base
Wall Mount with moveable arm
Ceiling Mount with moveable arm
Contrast Media Housing with Heater | Injector Base
Wall Mount with moveable arm
Ceiling Mount with moveable arm
Contrast Media Housing with Heater | The accessories of the
ulrichINJECT CT motion are
identical to the system
components of the previously
cleared ulrichINJECT CT
motion (K171392). |
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
| Disposables | ulrichINJECT CT Motion Pump Tubing-
flex
Patient Tubing for Pump Tubing-flex
ulrichINJECT CT Motion Spike for CT | ulrichINJECT CT Motion Pump Tubing-
flex
Patient Tubing for Pump Tubing-flex
ulrichINJECT CT Motion Spike for CT | The disposables of the
ulrichINJECT CT motion are
identical to the disposables of
the previously cleared
ulrichINJECT CT motion
(K171392). |
| Physical Design | | | |
| Weight | Injector (pedestal version): Approx. 80
kg
Injector (ceiling and wall mount
version): Approx. 40 kg
Terminal: Approx. 3 kg | Injector (pedestal version): Approx. 80
kg
Injector (ceiling and wall mount
version): Approx. 40 kg
Terminal: Approx. 3 kg | The weight of the
ulrichINJECT CT motion is
identical to the weight of the
previously cleared
ulrichINJECT CT motion
(K171392). |
| Dimensions | Injector (pedestal version and wall
mount version): 64.5 x 64.5 x 144.5 cm
Injector (ceiling version): Depends on
the system selected and the length of
the fixed height arm
Terminal: 31 x 27.5 x 17 cm | Injector (pedestal version and wall
mount version): 64.5 x 64.5 x 144.5 cm
Injector (ceiling version): Depends on
the system selected and the length of
the fixed height arm
Terminal: 31 x 27.5 x 17 cm | The dimensions of the
ulrichINJECT CT motion are
identical to the dimensions of
the previously cleared
ulrichINJECT CT motion
(K171392). |
| Power Requirement
Rated Voltage:
Rated Current:
Rated Frequency: | 110 to 240 V AC
1.6 A
50/60Hz | 110 to 240 V AC
1.6 A
50/60Hz | The power requirements of the
ulrichINJECT CT motion are
identical to the power
requirements of the previously
cleared ulrichINJECT CT
motion (K171392). |
| Battery | Lead gel battery or Li-Ion battery | Lead gel battery | The battery of the
ulrichINJECT CT motion is
different from the previously
cleared ulrichINJECT CT
motion (K171392). This
difference does not affect the
intended use or safety or
effectiveness of the device. |
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
| Display Type | Color LCD Terminal with touch screen | Color LCD Terminal with touch screen | The display of the
ulrichINJECT CT motion is
identical to the display of the
previously cleared
ulrichINJECT CT motion
(K171392). |
| Characteristics | | | |
| Syringeless system | Yes | Yes | ulrichINJECT CT motion is
identical to the previously
cleared ulrichINJECT CT
motion (K171392). Both
systems are syringeless. |
| Remote Operation | Yes, via the Touch Terminal | Yes, via the Touch Terminal | ulrichINJECT CT motion is
identical to the previously
cleared ulrichINJECT CT
motion (K171392). Both
systems provide remote
operation. |
| Single Patient Use
Disposable | Patient Tubing for Pump Tubing-flex | Patient Tubing for Pump Tubing-flex | The single patient use
disposable of the
ulrichINJECT CT motion is
identical to the previously
cleared ulrichINJECT CT
motion (K171392). |
| Designed to Prevent
Reuse of Disposables | Yes - via the use of software controls | Yes - via the use of software controls | ulrichINJECT CT motion is
identical to the previously
cleared ulrichINJECT CT
motion (K171392). Both
systems provide software
controls to prevent user from
reuse of disposables. |
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
| Rotary peristaltic
pump | Yes | Yes | The rotary peristaltic pump of
the ulrichINJECT CT motion is
identical to the rotary
peristaltic pump of the
previously cleared
ulrichINJECT CT motion
(K171392). |
| Used to administer
contrast media and
saline | Yes | Yes | ulrichINJECT CT motion is
identical to the previously
cleared ulrichINJECT CT
motion. Both systems are
used to administer contrast
media and saline. |
| Disposable uses
spikes to spike media
container | Yes | Yes | ulrichINJECT CT motion is
identical to the previously
cleared ulrichINJECT CT
motion. Both systems have
disposables which use spikes
to spike media containers. |
| Safety Stop
Mechanism | Multi-layered software stops; Used
Patient Tubing detector and Pump
Tubing-flex detector | Multi-layered software stops; Used
Patient Tubing detector and Pump
Tubing-flex detector | The safety stop mechanism of
the ulrichINJECT CT motion is
identical to the safety stop
mechanism of the previously
cleared ulrichINJECT CT
motion. |
| Volume Remaining
Readout | Yes, displayed on control unit if
programmed volume is higher than
remaining volume | Yes, displayed on control unit if
programmed volume is higher than
remaining volume | The volume remaining readout
of the ulrichINJECT CT motion
is identical to the volume
remaining readout of the
previously cleared
ulrichINJECT CT motion. |
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
| Programmable
Pressure Limit | Yes, 195 PSI; user-programmable or
automatic | Yes, 195 PSI; user-programmable or
automatic | The programmable pressure
limit of the ulrichINJECT CT
motion is identical to the
programmable pressure limit
of the previously cleared
ulrichINJECT CT motion. |
| Operational Characteristics | | | |
| Injection Capabilities | 40 phases per protocol | 40 phases per protocol | The injection capabilities of the
ulrichINJECT CT motion are
identical to the injection
capabilities of the previously
cleared ulrichINJECT CT
motion. |
| Injection Rates for
Contrast Media | 0.1 mL/s to 10.0 mL/s | 0.1 mL/s to 10.0 mL/s | The injection rates for contrast
media of the ulrichINJECT CT
motion are identical to the
injection rates for contrast
media of the previously
cleared ulrichINJECT CT
motion. |
| Injection Rates for
Saline | 0.1 mL/s to 10.0 mL/s | 0.1 mL/s to 10.0 mL/s | The injection rates for saline of
the ulrichINJECT CT motion
are identical to the injection
rates for saline of the
previously cleared
ulrichINJECT CT motion. |
| Injection Volume per
Injection | 1 to 200 mL max volume of contrast
media per patient with a max of 400
mL total media (contrast and saline)
per patient | 1 to 200 mL max volume of contrast
media per patient with a max of 400
mL total media (contrast and saline)
per patient | The injection volume per
injection of the ulrichINJECT
CT motion is identical to the
injection volume per injection
of the previously cleared
ulrichINJECT CT motion. |
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
| Flow Rate and
Volume Accuracy | 10-200 mL of contrast media with
volume accuracy of ± 5%
Flow rate accuracy of ± 5% | 10-200 mL of contrast media with
volume accuracy of ± 5%
Flow rate accuracy of ± 5% | The flow rate and volume
accuracy of the ulrichINJECT
CT motion is identical to the
flow rate and volume accuracy
of the previously cleared
ulrichINJECT CT motion. |
| Contrast Media
Container Volume | 500 mL (OMNIPAQUE™ IBP)
100 mL and 150 mL (VISIPAQUE™
single dose)
150 mL (OMNIPAQUE™ single dose) | 500 mL (OMNIPAQUE™ IBP) | The contrast media container
volume of the ulrichINJECT
CT motion is equivalent to the
contrast media container
volume of the previously
cleared ulrichINJECT CT
motion.
The only difference is that the
ulrichINJECT CT Motion
includes an additional contrast
media container volumes for
Omnipaque and Visipaque.
This difference has been
addressed with the completion
of a process simulation study. |
| Compatible Contrast
Media | OMNIPAQUE™ IBP
OMNIPAQUE™ single dose
VISIPAQUE™ single dose | OMNIPAQUE™ IBP | The compatible contrast media
of the ulrichINJECT CT motion
is different from the compatible
contrast media of the
previously cleared
ulrichINJECT CT motion. |
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
| | | | This difference has been
addressed with the completion
of contamination control
studies, extractable and
leachable studies, and bench
testing. |
| Saline Flush | Yes | Yes | The saline flush feature of the
ulrichINJECT CT motion is
identical to the saline flush
feature of the previously
cleared ulrichINJECT CT
motion. |
| Needle Size | 14-24 G | 14-24 G | The needle size of the
ulrichINJECT CT motion is
identical to the needle size of
the previously cleared
ulrichINJECT CT motion. |
| Injection Pause | Programmable - 0 sec to 999 sec in 1
sec increments | Programmable - 0 sec to 999 sec in 1
sec increments | The injection pause of the
ulrichINJECT CT motion is
identical to the injection pause
of the previously cleared
ulrichINJECT CT motion. |
| Injection Protocol
Storage | Yes | Yes | The injection protocol storage
of the ulrichINJECT CT motion
is identical to the injection
protocol storage of the
previously cleared
ulrichINJECT CT motion. |
| Priming/Venting Rate | 2 mL/s (manual) | 2 mL/s (manual) | The priming/venting rate of the
ulrichINJECT CT motion is
identical to the priming/venting
rate of the previously cleared
ulrichINJECT CT motion. |
| Characteristic | ulrichINJECT CT motion
( Subject Device ) | ulrichINJECT CT motion (K171392)
( Primary Predicate ) | Comparison |
| Air Detection
Principle | Ultrasound | Ultrasound | The air detection principle of the ulrichINJECT CT motion is identical to the air detection principle of the previously cleared ulrichINJECT CT motion. |
| Technical Detection
Limit of air in tubing | 0.05 mL | 0.05 mL | The technical detection limit of air in tubing of the ulrichINJECT CT motion is identical to the technical detection limit of air in tubing of the previously cleared ulrichINJECT CT motion. |
| Air Detector Alarm
Limit | 1 mL | 1 mL | The air detector alarm limit of the ulrichINJECT CT motion is identical to the air detector alarm limit of the previously cleared ulrichINJECT CT motion. |
| Occlusion Detection
Principle | Fail safe piezo-resistive pressure
sensor | Fail safe piezo-resistive pressure
sensor | The occlusion detection principle of the ulrichINJECT CT motion is identical to the occlusion detection principle of the previously cleared ulrichINJECT CT motion. |
| Occlusion Detection
Alarm Limit | 246 PSI | 246 PSI | The occlusion detection alarm limit of the ulrichINJECT CT motion of the occlusion detection alarm limit of the previously cleared ulrichINJECT CT motion. |
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
| Disposables | | | |
| Time Limit for
Disposables | 24 hours for ulrichINJECT CT Motion
Pump Tubing-flex
12 hours for Patient Tubing for Pump
Tubing-flex
8 hours for ulrichINJECT CT Motion
Spike for CT | 24 hours for ulrichINJECT CT Motion
Pump Tubing-flex
12 hours for Patient Tubing for Pump
Tubing-flex
8 hours for ulrichINJECT CT Motion
Spike for CT | The time limit for disposables
of the ulrichINJECT CT motion
is identical to the time limit for
disposables of the previously
cleared ulrichINJECT CT
motion. |
| Package Sterile | Yes | Yes | The sterile packaging of the
ulrichINJECT CT motion
disposables is identical to the
sterile packaging of the
previously cleared
ulrichINJECT CT motion. |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | The sterilization method of the
ulrichINJECT CT motion is
identical to the sterilization
method of the previously
cleared ulrichINJECT CT
motion. |
| Packaging
Configuration | Tyvek lid covering polystyrele tray | Tyvek lid covering polystyrele tray | The packaging configuration of
the ulrichINJECT CT motion is
identical to the sterilization
method of the previously
cleared ulrichINJECT CT
motion. |
| Patient Tubing | | | |
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
| Components | Patient Tubing
Two Patient Luer Connectors with
safety caps
Two check valves | Patient Tubing
Two Patient Luer Connectors with
safety caps
Two check valves | The patient tubing
components of the
ulrichINJECT CT motion are
identical to the patient tubing
components of the previously
cleared ulrichINJECT CT
motion. |
| Safety Feature
Against Re-use | Yes, via software controls | Yes, via software controls | The safety features to protect
against reuse of patient tubing
for the ulrichINJECT CT
motion are identical to the
safety features to protect
against reuse of patient tubing
for the previously cleared
ulrichINJECT CT motion. |
| Pump Tubing-flex | | | |
| Components | Contrast media lines x2
Saline Line
W-piece
Pressure sensor unit with integrated
particle filter
Check valve
Swabable valves x 4 | Contrast media lines x2
Saline Line
W-piece
Pressure sensor unit with integrated
particle filter
Check valve
Swabable valves x 4 | The pump-tubing flex
components of the
ulrichINJECT CT motion are
identical to the pump-tubing
flex components of the
previously cleared
ulrichINJECT CT motion. |
| Contrast Media Line
Tubing Material | PVC / PUR | PVC / PUR | The pump tubing-flex contrast
media line tubing material of
the ulrichINJECT CT motion is
identical to the pump tubing-
flex contrast media line tubing
material of the previously
cleared ulrichINJECT CT
motion. |
| Characteristic | ulrichINJECT CT motion
(Subject Device) | ulrichINJECT CT motion (K171392)
(Primary Predicate) | Comparison |
| Saline Line Tubing
Material | PVC / PUR | PVC / PUR | The pump tubing-flex saline
line tubing material of the
ulrichINJECT CT motion is
identical to the pump tubing-
flex saline line tubing material
of the previously cleared
ulrichINJECT CT motion. |
| Spike for CT | | | |
| Spike Size | 28.5 mm | 28.5 mm | The spike size of the
ulrichINJECT CT motion is
identical to the spike size of
the previously cleared
ulrichINJECT CT motion. |
| Safety Feature
Against Re-Use | Yes, via software controls | Yes, via software controls | The safety feature against re-
use of spikes for the
ulrichINJECT CT motion is
identical to the safety feature
against re-use of spikes for the
previously cleared
ulrichINJECT CT motion. |
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In conclusion, the intended use for ulrichINJECT CT motion is the same as that of the previously cleared ulrichINJECT CT motion (K171392). The technological characteristics demonstrate that the ulrichINJECT CT motion is equivalent to previously cleared ulrichINJECT CT motion (K171392), and the testing shows that the ulrichINJECT CT motion is substantially equivalent to the previously cleared ulrichNJECT CT motion (K171392) and assures that the ulrichNJECT CT motion is as safe and effective as the previously cleared ulrichINJECT CT motion (K171392).
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Non-Clinical Testing
ulrichINJECT CT motion system and software were validated in accordance with a Verification & Validation plan to ensure conformance with established performance criteria.
Software:
Software verification and validation was performed as part of K171392 and has been repeated for the software updates made as part of this submission. FDA's guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA Staff" (2005) has been followed.
Validation included an installation qualification and an operational / performance qualification. The ulrichINJECT CT motion software is unconditionally acceptance criteria for the Installation Qualification and Operational and Performance Qualification are satisfactorily met so that the Software is released for its intended use.
Electromagnetic Compatibility / Electrical Safety
Testing was performed in accordance with the following standards as part of K171392:
- . IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-2: Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
Additional EMC Testing has been performed to demonstrate conformance to IEC 60601-1-2 4th edition.
Testing results indicate that the ulrichINJECT CT motion complies with the standards listed.
Sterilization:
The ulrichINJECT CT motion tubing system is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10-6 in accordance with the following standard prior to commercial distribution:
- . ISO 11135-1: Sterilization of health care products-Ethylene oxide - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices; 2007
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard.
Shelf-Life:
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Real time aging and accelerating aging studies were performed as part of K171392. Additional real time aging shelf-life data is also provided for this submission. The ulrichINJECT CT motion tubing system is sterilized and its packaging was validated in accordance with the following standard:
- ISO 11607-1: Packaging for terminally sterilized medical devices Part 1: requirements . for materials, sterile barrier systems and packaging systems; 2006
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard.
Chemical Compatibility
Material compatibility of the ulrichINJECT CT motion tubing system was performed using Omnipaque™ and Visipaque™ as the solvents. The results of the testing concluded that the ulrichINJECT CT motion tubing system does not interact with Omnipaque™ or Visipaque™ and the chemical integrity of Omnipaque™ or Visipaque™ is not compromised throughout use. Therefore, ulrichINJECT CT motion is safe and effective for its intended uses.
Contamination Control:
ulrich has performed the following contamination control studies:
- . Process Simulation Studies
- . Microbial Ingress Study
- Cross Contamination Study
- . Rinsing Study
Contamination control study results has concluded that ulrichINJECT CT motion has the ability to maintain the sterility of the injection media and resist the ingress of microorganisms when used with Omnipaque™ Imaging Bulk Package (IBP), Omnipaque single dose bottles, and Visipaque single dose bottles during its intended use. Additionally, it has been concluded that the residuals between the single active compounds (lohexol and lodixanol) after rinsing the system with physiological saline solution are within the defined limits.
Biocompatibility:
The ulrichINJECT CT motion tubing system indirect patient contact materials were verified in accordance with the following standard as part of K171392:
-
. ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process: 2009
The following tests have been performed: -
. Cytotoxicity
-
Intracutaneous reactivity
-
Allergic sensitization
-
Systemic acute toxicity
-
Pyrogens
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- . Hemocompatibility: Hemolysis
- LAL test: Bacterial endotoxins ●
Verification results indicated that the materials comply with the standard.
Extractables and Leachables
Testing was performed for extractables and simulation testing for leachable compounds and particulates as part of K171392 for OMNIPAQUE. This testing was repeated for VISIPAQUE for this submission.
Testing and a toxicological assessment demonstrated that ulrichINJECT CT motion is safe and effective for its intended uses. The results of the testing and toxicological assessment met the requirements of the pre-defined acceptance criteria for the intended uses of the device.
Performance - Bench:
The ulrichINJECT CT motion tubing system was tested for performance and verified in accordance with the following standards as part of K171392:
- ISO 8536-4: Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; 2010
ulrichINJECT tubing system is not a gravity feed device. Therefore, only the applicable requirements from ISO 8536-4 were tested.
Transport validation and cleaning instructions validation was also performed as part of K171392.
Although the components of ulrichINJECT CT motion system have not changed since K171392, additional verification testing has been performed to further confirm that mixing of contrast media will not occur.
Test and verification results indicate that the ulrichINJECT CT motion tubing system conforms to its predetermined specifications and the applicable standards
Conclusion
Based on the performance testing, comparison, and analysis in this submission, the subject device ulrichINJECT CT motion is substantially equivalent to the predicate device, K171392.